scholarly journals Population Pharmacokinetic Analysis of Dexmedetomidine in Children using Real-World-Data Obtained from Electronic Health Records and Remnant Clinic Samples

2021 ◽  
Author(s):  
Nathan T James ◽  
Sara L Van Driest ◽  
Prince J Kannankeril ◽  
Leena Choi
Keyword(s):  
Real World ◽  
Volume Of Distribution ◽  
Pharmacokinetic Analysis ◽  
Population Pharmacokinetic ◽  
Real World Data ◽  
World Data ◽  
Fixed Weight ◽  
Population Pk ◽  
Study Population ◽  
The Impact

Dexmedetomidine is commonly used as part of intraoperative anesthetic management and for sedation and pain control after surgery in children. Dexmedetomidine infusion dose is typically given on a fixed weight basis with titration to achieve sedation goals while avoiding potential toxicities. Pharmacokinetic (PK) studies are useful for accurate prediction of the individual dose required to achieve sedation and analgesia goals without toxicity, but lack of PK data is a challenge in precision dosing for pediatric populations. In this study, population PK models were developed using a nonlinear mixed-effects modeling approach and used to explore the relationship between PK profile and clinical, demographic, and genotype covariates. A simulation study was used to demonstrate the impact of important covariates on concentration using a fixed weight dosing scheme. Our final study population included data from 354 patients age 0 to 22 years (median age 16 months). In the final two-compartment model with fixed allometric weight scaling we found significant effects of both age and UGT2B10 genotype. The population PK parameter estimates (95% confidence interval) for a standard 70 kg weight were clearance 22.3 (18.3 - 27.3) L/hr, central compartment volume of distribution 133 (112 - 157) L, intercompartmental clearance 24.1 (19.4 - 29.9) L/hr, peripheral compartment volume of distribution 5230 (3310 - 8260) L. Our study provides support for the feasibility of using real-world data obtained from EHRs and remnant samples to perform population PK analysis for groups of patients where traditional PK studies are challenging to perform. Inclusion of UGT2B10 genotype in the model significantly improved the model fit, but the effects were not large enough to impact clinical dosing.

scholarly journals The Impact of the Covid-19 Pandemic with Hidradenitis suppurativa Being Treated with Adalimumab: Evidence from Real-World Data

2020 ◽  
Vol 5 (4) ◽  
Author(s):  
Turkmen M
Keyword(s):  
Real World ◽  
Hidradenitis Suppurativa ◽  
Real World Data ◽  
Observational Analysis ◽  
World Data ◽  
Related Disease ◽  
Number Of Patients ◽  
Adalimumab Therapy ◽  
Study Population ◽  
The Impact

Background: There is uncertainty concerning the outcome of coronavirus disease-19 (COVID-19) infections in patients who are receiving adalimumab for hidradenitis suppurativa (HS) treatment. Objectives: This study aims to investigate the effect of adalimumab in HS patients during COVID 19 outbreak. Methods: We performed a retrospective observational analysis of the moderate-to-severe HS patients under adalimumab therapy, with reporting the number of patients hospitalized or who died from COVID 19 infection between 13 March 2020 and 31 July 2020. Results: Eighty nine patients who continued their therapy during pandemic were evaluated retrospectively. There were no cases of death from COVID-related disease in our study population or patients hospitalized for COVID-related disease. Conclusions: We suggest continuing the treatment of ADA in HS patients, under COVID-19 pandemic.

PD-0776 A Bayesian approach to evaluate the impact of change in IGRT protocol using real world data

2021 ◽  
Vol 161 ◽  
pp. S608
Author(s):  
I. Fornacon-Wood ◽  
H. Mistry ◽  
C. Johnson-Hart ◽  
J.P.B. O’Connor ◽  
C. Faivre-Finn ◽  
...  
Keyword(s):  
Bayesian Approach ◽  
Real World ◽  
Real World Data ◽  
World Data ◽  
The Impact

VP08 Real-World Data Use In Health Technology Assessments: A Comparison Of Five Health Technology Assessment Agencies

2017 ◽  
Vol 33 (S1) ◽  
pp. 149-150
Author(s):  
Amr Makady ◽  
Ard van Veelen ◽  
Anthonius de Boer ◽  
Hans Hillege ◽  
Olaf Klunger ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Relative Effectiveness ◽  
Internal Validity ◽  
Health Technology ◽  
Real World Data ◽  
World Data ◽  
The Impact

INTRODUCTION:Reimbursement decisions are usually based on evidence from randomized controlled trials (RCT) with high internal validity but lower external validity. Real-World Data (RWD) may provide complimentary evidence for relative effectiveness assessments (REA's) and cost-effectiveness assessments (CEA's) of treatments. This study explores to which extent RWD is incorporated in REA's and CEA's of drugs used to treat metastatic melanoma (MM) by five Health Technology Assessment (HTA) agencies.METHODS:Dossiers for MM drugs published between 1 January 2011 and 31 December 2016 were retrieved for HTA agencies in five countries: the United Kingdom (NICE), Scotland (SMC), France (HAS), Germany (IQWiG) and the Netherlands (ZIN). A standardized data-extraction form was used to extract data on RWD mentioned in the assessment and its impact on appraisal (for example, positive, negative, neutral or unknown) for both REA and CEA.RESULTS:In total, fourty-nine dossiers were retrieved: NICE = 10, SMC = 13, IQWiG = 16, HAS = 8 and ZIN = 2. Nine dossiers (18.4 percent) included RWD in REA's for several parameters: to describe effectiveness (n = 5) and/or the safety (n = 2) of the drug, and/or the prevalence of MM (n = 4). CEA's were included in 25/49 dossiers (IQWiG and HAS did not perform CEA's). Of the twenty-five CEA's, twenty (80 percent) included RWD to extrapolate long-term effectiveness (n = 19), and/or identify costs associated with treatments (n = 7). When RWD was included in REA's (n = 9), its impact on the appraisal was negative (n = 4), neutral (n = 2), unknown (n = 1) or was not discussed in the appraisal (n = 2). When RWD was included in CEA's (n = 11), its impact on the appraisal varied between positive (n = 2), negative (n = 5) and unknown (n = 4).CONCLUSIONS:Generally, RWD is more often included in CEA's than REA's (80 percent versus 18.4 percent, respectively). When included, RWD was mostly used to describe the effectiveness of the drug (REA) or to predict long-term effectiveness (CEA). The impact of RWD on the appraisal varied greatly within both REA's and CEA's.

550 Real World Treatment Trends for Patients TBSA ≤ 20%: Evaluating Important Shifts in Care and Budget Impact of ASCS Adoption

2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S115-S115
Author(s):  
James H Holmes ◽  
Stacey Kowal ◽  
Cheryl P Ferrufino
Keyword(s):  
Survey Data ◽  
Resource Use ◽  
Real World ◽  
Budget Impact ◽  
Patient Characteristics ◽  
Real World Data ◽  
Treatment Pathways ◽  
World Data ◽  
Burn Care ◽  
The Impact

Abstract Introduction Treatment pathways in burn care are typically determined based on burn center (BC) and patient characteristics, although decisions may be influenced by anecdotal experience, personal preference, and hospital policies/purchasing decisions. Health economic (HE) evaluations can support improved decision-making, identifying the most cost-effective interventions for tailored care. A novel burn care model (BEACON) was developed with burn surgeons over several years and validated through numerous publications, including an assessment of the HE impacts of autologous skin cell suspension (ASCS) use for definitive burn closure. To ensure that BEACON accurately represents the current state of care, it is vital to update data that underpins model projections. This study collected real world data on practice patterns and patient outcomes for the most commonly seen burns (TBSA ≤ 20%) to update the current understanding of standard of care (SOC) costs and outcomes and to refine estimates on the impact of ASCS use in TBSA ≤ 20% patients. Methods Data was collected from a 10% sample of BCs, including: BC and patient characteristics, resource use, inpatient costs, and length of stay (LOS). NBR based inputs in BEACON were updated to reflect survey data for patients with TBSA ≤ 20%, with the ability to view data as a national aggregate sample and across BC characteristics. BEACON estimates patient and BC costs and outcomes across a spectrum of patient profiles (age, gender, inhalation injury, comorbidity status, burn depth, TBSA) and combines information on each patient profile to understand annual budget impact. Key outcomes were compared across the survey sample and published NBR trends. Using the updated BEACON, the BC budget impact of ASCS in burns TBSA ≤ 20% was assessed. Results The survey was collected from 16+ BCs, focusing on inpatient encounters in 2018. LOS was lower than NBR estimates, with some centers reporting LOS per %TBSA far below 1 d/%TBSA. Using the detailed bottom-up estimation of cost from BEACON with survey data, trends suggest total hospital costs for SOC are lower than published NBR charges given shorter LOS and updated cost and resource use assumption. Conclusions Compared to NBR 8.0, contemporary data suggests that fewer small TBSA burns are being treated in the inpatient setting; those treated have a LOS below NBR estimates. When using real world data, the impact of ASCS use in burns TBSA ≤ 20% was still calculated to be cost saving to a BC overall, given reductions in LOS and number of definitive closure procedures. Incorporating ASCS into appropriate TBSA ≤ 20% procedures can still result in a positive financial impact for BCs. Applicability of Research to Practice

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